President and Managing Partner
Peter Latham has twenty years in general management and thirteen years in financial, strategic and business development consulting to the biotech industry. As founder and president of New Venture Advisors, Inc., then BioPharm Services, Inc. (which became Latham BioPharm Group), Mr. Latham has worked with a variety of companies ranging from large pharmaceutical companies to biotechs, venture capitalists and start-up entities. He has served as Acting President and on a variety of boards for clients ranging from start-ups to publicly traded companies. Prior to this, Mr. Latham was V.P. Engineering and Licensing for Drug Delivery Development, Inc. (DDD) where he managed the US operations and negotiated several large licenses for a drug delivery firm based in France. Prior to DDD, Mr. Latham was Subsystem Manager at McDonnell Douglas responsible for all of the cargo handling systems and interiors on the USAF C-17 program.
Mr. Latham holds a B.S. in Mechanical Engineering from Rensselaer Polytechnic Institute, an M.S. in Management from Massachusetts Institute of Technology’s Sloan School, and is a certified Program Manager (PgMP) with the PMI.
Partner, Government Practice Lead
Michael McGinnis has over twenty years of international business development, strategic planning, marketing, program management and general management experience in the Pharmaceutical and Biotechnology industries. He has senior level experience in both the commercial and government sectors, and a strong track record of achieving organizational growth targets. Most recently, as Director of New Business for DynPort Vaccine Company (DVC – a reputable biodefense product development organization within the Fortune 200 company CSC), Mr. McGinnis was responsible for leading the company’s new business activities and functions in the US Government sector. He was actively engaged with client organizations including CBMS, DTRA, BARDA and NIAID and teaming partners, i.e. CROs, Pharma/Biotech, and CMOs. As part of this role, Mr. McGinnis was responsible for all aspects of new business, including providing strategic oversight of both technical and budgetary aspects of proposals in response to US Government medical countermeasure advanced development program solicitations. Prior to joining DVC, he worked at ICON Clinical Research, as Executive Director of Sales, and at MedTrials, Inc. as the Associate Director of Business Development & Marketing, and held various leadership roles with global business development and marketing responsibilities for the CROs in the Biopharmaceutical, Pharma and Medical Device industries.
Mr. McGinnis earned a B.S. in Business Administration from Towson University, an M.B.A. from Loyola University Maryland, and an M.S. in Biotechnology from Johns Hopkins University.
Susan Dexter has over twenty-five years of experience in biotechnology science and business development. Ms. Dexter worked as a scientist doing cell culture and small scale manufacturing, before moving into the business of science and selling biotechnology contract manufacturing services ranging from process development through commercial manufacturing, and strategic consulting related services. Ms. Dexter has supported multiple start-up companies as well as established biotech, pharmaceutical and technology companies, performing strategic business development, M&A , and technology in- and out-licensing. Prior to joining Latham Biopharm Group, Ms. Dexter was Chief Business Officer at Xcellerex, Inc. responsible for all aspects of business development for contract manufacturing services (CMO), and the sale of disposable technologies and integrated modular manufacturing facilities (FlexFactory®). Prior to Xcellerex, Ms. Dexter was the VP of Business Development at The Dow Chemical Company after developing a $7.0M CMO business at the Collaborative BioAlliance, and then selling it to Dow. She was also the Assoc. Director of Business Development (and was the first US employee) of Celltech, then Lonza, where she identified and closed commercial supply agreements in excess of $650M and negotiated over twenty gene expression technology licenses worth over $250M.
Ms. Dexter holds a double major with Honors in Immunology and Marketing from American University, Washington, D.C., a graduate of the ‘Negotiation for Lawyers” course, Harvard University; she also lectures annually at University College London (credit course) and presents regularly at a variety of industry conferences.
Mr. Newton has over thirty years of experience in the design and management of technical development programs often working directly with government agencies. He has managed the design, build and validation of specialized pharmaceutical automation systems and instruments and the development of advanced concepts for manufacturing of pharmaceuticals. In his last position, Mr. Newton was Division Manager at Foster Miller, now QinetiQ North America, where in addition to building the business segment, he managed the early stage development of a technology for manufacturing drug products in a miniaturized system for battlefield applications. Prior to Foster Miller, Mr. Newton was Director of Thermal Technologies for OHM Remediation Services where he was responsible for the design, installation and validation of chemical process systems under the EPA Superfund program . In these capacities and at Latham BioPharm Group, Mr. Newton has won and managed projects working with the U.S. Navy, Army Corps of Engineers and DARPA.
Mr. Newton holds both a B.S. and an M.S. in Mechanical Engineering from Tufts University and is an active member of ISPE, PMI, and ALA.
Joshua Speidel, Ph.D.
Managing Director, Commercial Practice Lead
Dr. Speidel leads the development and execution of a Product Development Management, Strategic Analysis, and Medical Device / Diagnostic Development service offerings at LBG providing subject matter expertise and advisory services on pharmaceutical product development, mergers and acquisition, strategic business development, and due diligence to clients. Dr. Speidel is a biotechnology product development professional with experience from pre-discovery through lifecycle management of mature products destined for the HHS Pandemic Influenza Vaccine Stockpile. Dr. Speidel provides technical expertise, program management and federal contract compliance support to clients. He has led teams in the submission of proposals resulting in $400M of awards. As a Health Scientist for the U.S. Department of Health and Human Services (HHS), Biomedical Research and Development Authority (BARDA), he led efforts to establish the core capabilities to support the licensure of medical countermeasures in the areas of manufacturing capacity, product development, clinical studies, and long-term stockpiling. At BARDA, Dr. Speidel was responsible for the post-licensure management of three pandemic influenza vaccine stockpile programs, one advanced development program for a licensed recombinant influenza vaccine, and the Clinical Studies Network program. The total contract values of these efforts were in excess of $17 billion. Earlier, while consulting to the U.S. Defense Advanced Research Projects Agency (DARPA), Dr. Speidel created programmatic concepts that were pitched to DARPA’s director and resulted in excess of $250M in contract awards, was the technical point of contact for two teams in the “Accelerated Manufacturing of Pharmaceuticals” program which pioneered efforts in recombinant vaccine production, and was the project manager for their $100M response to the H1N1 pandemic that built three tobacco based manufacturing facilities and advanced a pre-discovery stage vaccine candidate through a Phase 1 Clinical Trial, on time and on budget.
Dr. Speidel received a Ph.D. in Physiology and Biophysics from Cornell University, a M.Sc. in Biochemistry and Biophysics from the University of Houston and a B.S. in Biochemistry and Molecular Biology from Pennsylvania State University.
Timothy Alcorn, Ph.D.
Director, Medical Devices and Diagnostics
Dr. Timothy Alcorn is an experienced clinical chemist and molecular biologist with more than 25 years of experience in the healthcare industry. Throughout his career he has worked in a variety of healthcare sectors including reference laboratories, medical device manufacturing, medical software development, in vitro device development, and pharmaceutical development. He has extensive experience in infectious diseases having been the laboratory director at LabCorp’s Center for Molecular Biology and Pathology where he developed advanced clinical assays and ran a laboratory that generated over $50 million in revenue. In addition, he was Director of Clinical Affairs at Janssen Diagnostic Inc. where he helped bring new diagnostics and software to the global market to support the launch of drugs for the treatment of HIV and HCV. Dr. Alcorn has also overseen the development and global commercialization of medical devices including a handheld ultrasound device and wearable sensors for monitoring ECG and patient vitals. Dr. Alcorn served on the scientific advisory board for Roche Diagnostics for several years as well as other diagnostic companies. In addition, he has authored numerous publications, book chapters, and international clinical chemistry guidelines. Over the years Dr. Alcorn has also gained significant experience in global reimbursement, health economics, and commercialization. Additionally, Dr. Alcorn has experience in device and diagnostic regulations and is currently an adjunct professor at the Johns Hopkins University’s graduate regulatory science department where he teaches courses in IVD regulation and translational biotechnology.
Dr. Alcorn is a HIPAA Privacy and Security Expert and served as the privacy officer for a health medical records system. Dr. Alcorn started his career at the University of North Carolina working on sexually transmitted diseases pathobiology and vaccine development.
Robert P Casillas, Ph.D., Fellow ATS
Director, Nonclinical Consulting
Dr. Casillas is a business strategic professional and biochemical toxicologist with over 25 years’ nonclinical development experience identifying workable solutions for novel products in the Medical Countermeasures (MCM) and Companion Animal Health markets. This includes 20 years’ managing CRO chem/bio containment and preclinical facilities, along with over 350 staff. He provides a proven customer focus and value creation for Global clients, with demonstrated success in establishing strategic partnerships and cross-functional teams to develop new revenue streams and drive growth. Dr. Casillas formerly served as VP, Strategic Global Health Security (MRIGlobal); VP, CBRN Business Integration (Battelle); and VP, Biomedical S&T (Battelle), where he established strategic and tactical plans to facilitate awards of over $900M in multi-year contracts with government, industry, and academia. He has worked with government funded small/large Pharma, virtual Biotech, and Academia, the top small/large Global Animal Health companies, the DoD (i.e., DTRA, JPEO, DARPA), DHHS (i.e., BARDA, NIH, FDA, CDC), and DoE to develop national defense, public/animal health MCMs. He has overseen or consulted on 100’s of nonclinical projects for non-GLP and pivotal IND/NDA-enabling GLP studies (primarily FDA Animal Rule applications), target animal safety studies, toxicant and/or drug delivery, and formulation/device feasibility. He played a management/program/scientific role for eight EUA or FDA licensed medical CBRN defense products. Dr. Casillas is also a Colonel in the U.S. Army Reserve and serves as a CBRN medical defense SME for senior leaders.
Dr. Casillas is on the Board of the Missouri Biotechnology Association, KSU-Olathe, KU-Edwards, and recently on the Kansas City Animal Health Corridor Board. He is an Adjunct Professor in the Dept of Pharm/Tox, Rutgers University, and a Fellow of the Academy of Toxicological Sciences.
Dr. Casillas received his Ph.D. in Biochemistry and B.S. in Microbiology from Georgia State University and was a Post-Doctoral Fellow in the Department of Biochemistry, Center in Molecular Toxicology, at Vanderbilt University SOM.
Director, Government Consulting
Ms. Duchars has more than 20 years of experience in the pharmaceutical industry with 15 years focused on capturing government and non-dilutive funding for life sciences research and development programs. She began her career in R&D (animal model and assay development), moving on to program management, and finally on to business development, proposal management, capture management and alliance management. She recently joined Latham BioPharm Group where she focuses on providing leadership to LBG’s Government Consulting offering, including; strategic consulting on all aspects of securing non-dilutive funding from the federal government, conducting landscape and opportunity assessments, strategic positioning of client solutions, agency outreach, and proposal development services. Prior to working with Latham BioPharm Group, Ms. Duchars worked at Emergent BioSolutions as a Director of External Development, where she performed capture management, proposal management and relationship management activities that supported the successful establishment and management of United States Government contracts and collaborations in the development of medical countermeasures for chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza, and emerging infectious diseases. Before Emergent, Ms. Duchars was a Market/Relationship Manager and Program Manager at Battelle Memorial Institute, a Program Manager at DynPort Vaccine Company, and a Senior Research Assistant at Guilford Pharmaceuticals.
Ms. Duchars has been a certified Project Management Professional (PMP) since 2005, and a Certified Alliance Manager (CA-AM) since 2012. Ms. Duchars is a graduate of the Dickinson College.
Joseph Rininger, Ph.D.
Director, Cell and Gene Therapy
Dr. Rininger possesses over eighteen years of experience in basic biomedical research and biopharmaceutical product development program management with an emphasis on vaccines, adjuvants and gene therapy. As the Senior Director, Influenza at Protein Sciences Corporation (PSC), Dr. Rininger was the program manager of a BARDA contract for the advanced development and commercialization of Flublok®, the first approved recombinant hemagglutinin-based subunit vaccine for influenza. This encompassed planning and leading a cross-functional team in the execution of tasks involving all areas of recombinant vaccine development (process development, formulation development and stability, pre-clinical efficacy and toxicology, quality control/quality systems, process and facility validation, manufacturing process transfer, regulatory affairs and clinical development).
Prior to that role, he served as Director of Business Development and worked to secure new CMO programs, grew an established research product business unit evaluated in- and out-licensing of technology and performed writing and submission of NIH grant funding opportunities. He has solid skills in international business development, strategy and alliance management; working with CMOs, CROs, medical device company sterile filling technology, For the CMO projects PSC, he successfully oversaw project teams for the development of upstream and downstream processes for transfer to cGMP manufacturing of four vaccine candidates and two biologics. He also has experience in product development and program management of rAAV-based gene therapies and had a supportive regulatory role in the approval of Glybera, the first gene therapy to attain marketing approval. He has also supported three rAAV development programs for orphan diseases and authored the CMC section for a program that has entered human clinical trials.
Dr. Rininger earned a Ph.D. from Cornell University in Toxicology and a B.S. in Marine Biology with a Concentration in Biotechnology from Fairleigh Dickinson University. He has several awarded and pending patents and is well published in industry magazines and peer-reviewed journals.
Robert Huebner, Ph.D.
Dr. Robert Huebner is an experienced biotechnology program manager with over twenty-five years of research experience with viral and microbiological pathogens and expertise in the vaccine industry, group management, and program management. Throughout his career, he has worked for a variety of organizations, large pharma companies, government agencies, and a contract research organization, holding positions of increasing responsibility at each. Most recently, while working at the Biomedical Research and Development Authority (BARDA) of the Department of Health and Human Services, Dr. Huebner held several positions including Acting Director of the Influenza Division, Deputy Director and Chief of Universal Influenza Vaccine Development. While serving as Acting Director, he was responsible for over 50 programs valued in excess of $5 billion, highlighted by the licensure of three new types of influenza vaccines, and approval of a new near patient diagnostic platform for influenza and RSV. Prior to BARDA, at the Midwest Research Institute, now MRIGlobal, Dr. Huebner grew the client base for the biotechnology section he managed, bringing in awards from: the Department of Homeland Security for pathogen sensor development; the FDA’s Center for Food Safety and Applied Nutrition for pathogen detection in food; DynPort Vaccine Corporation (DVC) for assessment of vaccines in animal models; and other industrial clients for aerosol sciences studies. Dr. Huebner started his career as a bench scientist and group leader at Connaught Laboratories, now Sanofi Pasteur, working on applied research to develop new and improved vaccines against Lyme disease, influenza, Dengue, Japanese Encephalitis, malaria and pneumococcal disease.
Dr. Huebner received a Ph.D. in Molecular Biology and Microbiology from Tufts University in Boston, MA and a B.S. in Biology from Carnegie Mellon University, Pittsburgh, PA.
Nikki Nogal, Ph.D.
Dr. Nogal is an experienced Bioengineer with more than 15 years in cell culture research and industry. Throughout her career she has worked at a variety of biotechnology companies including Johnson and Johnson, Gilead and Genentech.
Dr. Nogal is an experienced CMC team leader with technical expertise in biologics process development, manufacturing science and commercial drug substance manufacturing. She has extensive experience in process characterization and process optimization having been lead for several key Mab and recombinant protein vaccine programs. Her responsibilities also included internal/external technology transfer into GMP/commercial manufacturing for production of biotherapeutic proteins and person-in-plant support for upstream campaigns. The scope of her expertise also includes JMP design and analysis of Process Characterization studies. She was also the lead for the analysis and control of post-translational modification of therapeutic proteins. In addition, she also led cell culture medium development and optimization efforts.
Most recently, Dr. Nogal was a Senior Engineer at Genentech where she served as the Technical Lead to improve titers and product quality for one of Genentech’s top tier products. She led upstream operations to optimize commercial scale performance activities for Biologics Drug Substance manufacturing by providing technical oversight for a multi-product, large scale, automated biopharmaceutical facility. She is adept at bringing Quality by Design (QbD) concepts to quality decisions, validation and audit risks. She also provided Drug Substance (Upstream) technical oversight to ensure consistent and continued process performance across the Roche network and played key roles in process improvements and global investigations.
Dr. Nogal graduated with BS and MS degrees in Chemical Engineering from the University of Maryland and her PhD in Biomedical Engineering from Florida State University. She completed postdoctoral training at Johnson & Johnson Pharmaceutical R&D, and University of California San Diego School of Pharmacology and Bioengineering.
Christopher Peterson is a PMI-certified (PMP) and APICS-certified (CSCP) project manager with almost ten years’ experience in validation, knowledge management, project management, and financial modeling in the Life Sciences industry. As a Consultant with Latham BioPharm Group, Mr. Peterson provides project management services, conducts market research and strategic analysis, and executes financial models in support of company valuations. He brings substantial quality, validation, and documentation management expertise to his clients, including management of their products’ life cycles. His clients include virtual companies through large pharma, and both private and public organizations.
Prior to joining LBG, Mr. Peterson was the business and technical lead at AstraZeneca for the implementation of a data aggregation and analytics software to support commercial process validation. In support of this project, he managed the coordination, configuration, validation, and implementation of the software including selection of the critical process parameters and source data systems, development of bioprocessing hierarchies, and creation of business processes and procedures. Mr. Peterson is also a subject-matter-expert in Microsoft’s SharePoint, administrated a SharePoint-based document management system, and has significant proficiency with multiple Quality Systems and software platforms. Starting his biotechnology career at Merck and Co. as a validation engineer, Mr. Peterson led projects in autoclave load pattern remediation, cleaning and sterilization validation for routine manufacturing, and change management for cleaning and sterilization validation. At Merck, he developed his skills in validation SOP generation, protocol writing, study execution, final report writing and review, and, in a special project, created standardized, CBER-ready protocols and final reports.
Mr. Peterson earned both his Bachelor of Science and Master of Science degrees in Chemical Engineering at Drexel University and is a Project Management Professional (PMP) as certified by the Project Management Institute.
Gretchen Stup brings more than fifteen years of experience in the management of government contracts, and over seventeen total years of experience working in a scientific environment to Latham BioPharm Group. At LBG, she serves as a Senior Consultant where she provides program management and systems integration support to government and client related projects for companies of different sizes. She is a certified Project Management Professional (PMP) and much of her experience lies in total project lifecycle management. Ms. Stup has successfully managed multiple government contracts, including Plague, Tularemia, Ebola, and Anthrax vaccine development projects. She supported the development of Vaccinia Immune Globulin (VIGIV), which was one of the first FDA-licensed biodefense products. Besides her in-depth experience in the management of government (including Prime) contracts, she has been involved in the management and oversight of various subcontracting organizations, ranging from small R&D facilities to large, complex CMOs and CROs. Ms. Stup has experience with the Animal Rule and has supported FDA filings and negotiations through product licensure. Prior to working in Program Management at LBG and previously at DynPort Vaccine Company (DVC), she co-developed and implemented DVC’s comprehensive Risk Management program, and worked as a Quality Assurance specialist at Boston Biomedica, Inc. (now Pressure BioSciences, Inc.).
Ms. Stup earned a Bachelor of Science degree from Shepherd University and is a Project Management Professional (PMP) as certified by the Project Management Institute.
Cassidy Cantin has worked within the Life Sciences industry for the better part of a decade providing Program Management and Product Leadership with specific experience vaccine and biosimilar development, as well as Business Development and Marketing expertise. As a Consultant for Latham BioPharm Group (LBG), Ms. Cantin will continue to use her knowledge of program management to help clients manage the successful planning and delivery of their government and commercial programs. Her extensive skills in primary and secondary market research and competitive intelligence analysis will assist clients in making strategic decisions and developing their corporate strategy. Prior to LBG, Ms. Cantin was the Senior Manager of Business Development and Marketing at Pfenex Inc., a biologics company focused on biosimilar development. In addition to her business development and marketing responsibilities there, she managed government sponsored programs totaling over $500M and supported a number of successful government proposal efforts.
Ms. Cantin is a certified Program Management Professional (PMP) and holds an MBA from San Diego State University with an emphasis in entrepreneurship and market research. She did her undergraduate work at University of California, San Diego where she earned a B.A. double major in Economics and Public Health. Ms. Cantin was the 2018 President of Women In Bio organization of professionals committed to promoting careers, leadership and entrepreneurship for women in the life science and currently serves on the Board of Directors.
Kimberly Weber has more than 17 years of experience leading and performing research in academic and industry laboratories in the areas of immunology, cell biology, molecular biology, virology, microbiology, and assay development and validation, with more than five years of experience in the management of government and commercial contracts. Ms. Weber received her Project Management Professional Certification from the Project Management Institute. She is currently employed by Latham BioPharm Group where she serves as a Consultant providing program management support to government and client-related projects for companies of varying sizes. Ms. Weber previously served as Project/Program Manager for the In Vitro Assay Services Department at Battelle managing highly complex biomedical research programs focused on assay development, diagnostic testing and evaluation, and nonclinical toxicology. Ms. Weber also served as a Research Scientist in the In Vitro Assay Services Department at Battelle where she led development and validation of immunology and molecular-based assays for biothreat, infectious disease, and pharmaceutical products targets. She began at Battelle as an analyst performing high-throughput sample analysis supporting infectious disease vaccine programs.
Ms. Weber began her career studying an in vitro model for Autosomal Dominant Polycystic Kidney Disease and is a graduate of Randolph-Macon College.
Rachel Schmitz, Ph.D.
Senior Associate Consultant
Dr. Schmitz is an Associate Consultant at LBG, and is actively involved in supporting clients of different sizes and provides programmatic support, as well as helping to manage the successful planning and delivery of government and commercial programs. This includes writing technical weekly, monthly and contractual reports as well as the daily aspects of program support. Dr. Schmitz also provides technical support to programs and reviews new life science products. Additionally, she assists with internal Business Development activities. Dr. Schmitz is a physical chemist with extensive research experience in optical spectroscopy and metal-enhanced fluorescence. Dr. Schmitz’ research experience is focused on the synthesis of fluorescent nanomaterials and the characterization of their optical properties through use of UV-vis spectroscopy, fluorescence and phosphorescence spectroscopy, time-correlated single photon counting (TCSPC), and lasers utilizing ocean optics software. Dr. Schmitz has written and assisted with several peer-reviewed scientific journal articles and presented her research at multiple scientific conferences.
Dr. Schmitz earned her Bachelor of Science in Chemistry at West Virginia Wesleyan College and her Ph.D. in Chemistry at the University of Maryland Baltimore County.
Ashley Fennell, Ph.D.
Dr. Ashley Fennell has over twelve years of research experience in behavioral neuroscience and addiction research using both dopaminergic cell lines and animal models. Her expertise is focused on molecular and cellular biology. Throughout her career, she has worked for a variety of academic organizations, holding senior positions with increasing responsibilities at each. The scope of her work has included managing and mentoring academic labs and departments through the creation of Standard Operating Procedures (SOPs) and establishing Good Laboratory Practice (GLP) studies in the field, as well as assisting in grant writing to aide in securing financial support for the labs. She started her career as a bench scientist at Wake Forest School of Medicine while working on accumbal catecholamine release following nicotinic receptor modulation (nAChR). She also piloted a project observing non-opioid sigma-1 receptor modulation on dopamine release following intracellular calcium manipulations. In addition to her strong program management skills, she has also supported IND preparation and submission activities for product development programs.
Dr. Fennell earned a Ph.D. in Biomedical Research from Meharry Medical College in Nashville, TN and a B.S. in Biology from The University of Georgia in Athens, Ga. She has published several papers in peer-reviewed journals that relate to her work as a bench scientist.
Lauren Schoukroun-Barnes, Ph.D.
Dr. Schoukroun-Barnes is a PMI-certified (PMP), APICS-certified (CSCP) project manager, and an analytical chemist with extensive research experience in bioanalytical sensor fabrication and utilization, specifically for the detection of small molecule targets directly in biological matrices. She brings her knowledge to Latham BioPharm Group (LBG) and works as an Associate Consultant, supporting multiple commercial and government programs, their planning and successful delivery. She leads and assists with the management of the day-to-day aspects of projects, and also provides technical support, reviews new life science products and technologies, and assists with internal Business Development efforts. Prior to joining LBG, Dr. Schoukroun-Barnes started her career as an Analytical Chemist at Pii (Pharmaceutics International, Inc), a multinational contract formulation development, Clinical Trial Materials (CTM), and commercial manufacturing company. There, she worked in an FDA and MHRA-regulated cGMP laboratory environment, running validation studies, completing tests for finished drug products (assay, impurity, and preservative methodologies) and samples (stability and release). She is also proficient in several laboratory software platforms and analytical and electrochemical methodologies.
Dr. Schoukroun-Barnes received her Bachelor of Science in Chemistry from Mount St. Mary’s University and her Ph.D. in Analytical Chemistry from the University of Maryland Baltimore County. She has published several peer-reviewed articles in various scientific journals and presented her research at industry conferences.